In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
The study is a prospective, multi-center, non-randomized, single arm, post-approval study of the approved RX
Acculink Carotid Stent System used in conjunction with Abbott Vascular¿s Accunet or Emboshield family of Embolic Protection Systems (EPS).
Study Population Description
The study population will include patients in whom a commercially available RX Acculink Carotid Stent
System is introduced into the carotid artery to treat a lesion in the internal carotid artery with or without involvement of the contiguous common carotid artery.
Sample Size
The study will enroll up to 350 clinical sites in the United States and at
least 1200 sequentially-enrolled subjects in whom a physician uses the RX Acculink Carotid Stent System.
Data Collection
Primary Endpoint: A composite rate of peri-procedural (within 30 days of the procedure) death and
stroke, plus ipsilateral stroke between day 31 and 1 year (365 days)
Secondary Endpoints
1. Composite of peri-procedural death and stroke by symptomatic status
2. Ipsilateral stroke at 2 and 3 years
3. Composite of peri-procedural death and stroke plus ipsilateral
stroke at 1, 2, and 3 years for octogenarians
4. Annual rate of clinically driven target lesion revascularization
through 3 years
Followup Visits and Length of Followup
24-hours post-procedure period, 30-days, 1-year and annually for a total of 3 years
